Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levobupivacaine hydrochloride
AbbVie Ltd
N01BB10
Levobupivacaine hydrochloride
.625mg/1ml
Infusion
Epidural
No Controlled Drug Status
Valid as a prescribable product
BNF: 15020000; GTIN: 5013158774209
PACKAGE LEAFLET: INFORMATION FOR THE USER CHIROCAINE 0.625 MG/ML OR 1.25 MG/ML SOLUTION FOR INFUSION FOR EPIDURAL USE ONLY LEVOBUPIVACAINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor or nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Chirocaine is and what it is used for 2. What you need to know before you are given Chirocaine 3. How you will be given Chirocaine 4. Possible side effects 5. How to store Chirocaine 6. Contents of the pack and other information 1. WHAT CHIROCAINE IS AND WHAT IT IS USED FOR Chirocaine belongs to a group of medicines called local anaesthetics. This type of medicine is used to make an area of the body numb or free from pain. Chirocaine solution for infusion is for adult use only. Chirocaine is used for pain relief: • after major surgery • during childbirth 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CHIROCAINE_ _ DO NOT TAKE CHIROCAINE: • if you are allergic (hypersensitive) to levobupivacaine, to any similar local anaesthetics or to any of the other ingredients of this medicine (listed in section 6) • if you have very low blood pressure • as a type of pain relief given by injection into the area around the neck of the womb (the cervix) during the early stage of labour (paracervical block) • to numb an area by injecting Chirocaine into a vein WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given Chirocaine if you have any of the diseases or conditions below. You may need to be checked more closely or given a smaller dose. • if you suffer from diseases of the nervous system • if you are weak or ill • if you are elderly • if you have liver disease. OTHER MEDICINES AND CHIROCAINE Tell your doctor or nurse if you are tak Lesen Sie das vollständige Dokument
OBJECT 1 CHIROCAINE 1.25MG/ML SOLUTION FOR INFUSION Summary of Product Characteristics Updated 07-Aug-2015 | AbbVie Limited 1. Name of the medicinal product Chirocaine 1.25 mg/ml solution for infusion 2. Qualitative and quantitative composition Levobupivacaine hydrochloride corresponding to 1.25 mg/ml levobupivacaine. Excipients with known effect: 3.6 mg/ml of sodium per bag. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for infusion Clear solution 4. Clinical particulars 4.1 Therapeutic indications Adults _Pain management_ Continuous epidural infusion, for the management of post operative pain and labour analgesia. 4.2 Posology and method of administration Levobupivacaine should be administered only by, or under the supervision of, a clinician having the necessary training and experience. Chirocaine Solution for Infusion is for epidural use only. It must not be used for intravenous administration. Type of block Concentration mg/ml Infusion Rate Per Hour ml mg _Continuous Infusion: _Post operative pain management 1.25 10-15 12.5-18.75 Lumbar epidural (analgesia in labour) 1.25 4-10 5-12.5 Careful aspiration before infusion is recommended to prevent intravascular injection. If toxic symptoms occur, the injection should be stopped immediately. There is limited safety experience with levobupivacaine therapy for periods exceeding 24 hours. In order to minimise the risk for severe neurological complications, the patient and the duration of administration of levobupivacaine should be closely monitored (see Section 4.4). Maximum dose The maximum dosage must be determined by evaluating the size and physical status of the patient. The maximum recommended dose during a 24 hour period is 400 mg. For post-operative pain management, the dose should not exceed 18.75 mg/hour, however the accumulated dose for a 24 hour period should not exceed 400 mg. For labour analgesia by epidural infusion, the dose should not exceed 12.5 mg/ hour. Paediatric population The safety and efficacy of levobupiva Lesen Sie das vollständige Dokument